Jobs

RA Manager or Senior Manager

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Published:   2020/01/23

Type

Full time

Category

Medical Device

Salary

¥ 15,000,000 ~ ¥ 17,000,000

Location

Tokyo

Description

Exclusive search for a well established medical device company with exciting product pipeline.

 

Title : RA Manager or Senior Manager

Location : Tokyo, Japan

Reporting : Global RA Head

Duties :

  • Overall leadership to ensure the smooth and swift product registration in the Japan market
  • Manage the efficient and effective preparation all necessary documentations by working closely with global R&D teams.
  • Manage the effective communication of RA team in the US and EU
  • Update, educate, coach or guide the R&D and other functional teams on local regulatory requirements and ensure necessary test and/or assessment of the new products to be completed in time.
  • Ensure the discipline among the employees around the PMDA regulatory requirement.

Team :

  • Line management of the team of 2-4 professionals.

 

Required Experience and Capabilities

  • 5+ years of experience in Regulatory Affairs experience in medical industry
  • 2+ years of people management experience.
  • Result oriented work attitude – not just managing the processes.
  • Resilience to changing environment and challenges

Language

  • Business level Japanese and English.